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United States Patent |
5,685,859
|
Kornerup
|
November 11, 1997
|
Device for fixating a drainage tube and a drainage tube assembly
Abstract
A device for fixating a drainage tube relative to a skin surface part of a
patient or person comprises a plaster component including a support foil
having an aperture for receiving said drainage tube, and opposite first
and second side surfaces, said first side surface being provided with an
adhesive layer for fixating said plaster component relative to said skin
surface part of said patient or person, a support component arranged
adjacent said aperture at said second side surface of said plaster
component and protruding therefrom, said support component having an outer
surface for supporting a length of said drainage tube extending from said
aperture at said second side surface of said plaster component so as to
turn said length of said drainage tube in supported relationship with said
support component from an orientation substantially perpendicular to said
skin surface part of said patient or person to an orientation
substantially parallel with said skin surface part of said patient or
person, and said support component and said plaster component being joined
together.
Inventors:
|
Kornerup; Niels (Roedovre, DK)
|
Assignee:
|
Nikomed Aps (Roedovre, DK)
|
Appl. No.:
|
454518 |
Filed:
|
May 30, 1995 |
Foreign Application Priority Data
| Jun 02, 1994[DK] | 94 00241 |
| Jan 13, 1995[DK] | 39/95 |
Current U.S. Class: |
604/180; 604/179 |
Intern'l Class: |
A61M 011/00 |
Field of Search: |
604/174,179,180
128/DIG. 26
|
References Cited
U.S. Patent Documents
4645492 | Feb., 1987 | Weeks | 604/174.
|
Foreign Patent Documents |
WO91/07204 | May., 1991 | WO.
| |
WO93/17738 | Sep., 1993 | WO.
| |
WO93/25264 | Dec., 1993 | WO.
| |
Primary Examiner: Rimell; Sam
Attorney, Agent or Firm: Vigil; Thomas R.
Claims
I claim:
1. A catheter or tube assembly for fixing a tube, such as a drainage tube
inserted through an opening in a patient's skin, relative to the patient's
skin, comprising:
a catheter or tube forming a drainage tube;
a plaster component including a support foil having an aperture for
receiving said drainage tube and having opposite first and second side
surfaces, said first side surface being provided with an adhesive layer
for fixing said plaster component relative to the patient's skin,
an outer support component arranged above said plaster component and
adjacent said aperture at said second side surface of said plaster
component and protruding therefrom,
said outer support component having an outer surface for supporting a
length of said tube extending from said aperture at said second side
surface of said plaster component for bending, without kinking, said
length of said tube in supported relationship with said outer support
component from an orientation substantially perpendicular to the patient's
skin to an orientation substantially parallel with the patient's skin,
and said outer support component and said plaster component being joined
together said assembly further including a cover for covering the outer
support component and tube assembly.
2. The catheter or tube assembly according to claim 1 wherein said outer
surface of said support component is rounded for supporting said length of
said tube in a curved configuration.
3. The catheter or tube assembly according to claim 1 wherein said plaster
component and said support component are joined together by means of a
connecting component.
4. The catheter or tube assembly according to claim 3 wherein said
connecting component is provided with an aperture, said connecting
component being attached to said first side surface of said plaster
component, and said aperture of said connecting component being in
registration with said aperture of said plaster component.
5. A catheter or tube assembly for fixing a tube, such as a drainage tube,
inserted through an opening in a patient's skin, relative to the patient's
skin, comprising:
a catheter or tube forming a drainage tube;
a plaster component including a support foil having an aperture for
receiving said drainage tube and having opposite first and second side
surfaces, said first side surface being provided with an adhesive layer
for fixing said plaster component relative to the patient's skin,
an outer support component arranged above said plaster component and
adjacent said aperture and said second side surface of said plaster
component and protruding therefrom,
said outer support component having an outer surface for supporting a
length of said tube extending from said aperture at said second side
surface of said plaster component for bending, without kinking, said
length of said tube in supported relationship with said outer support
component from an orientation substantially perpendicular to the patient's
skin to an orientation substantially parallel with the patient's skin, and
said outer support component and said plaster component being joined
together and said outer support component providing lateral support of
said length of the drainage tube said assembly further including a cover
for covering the outer support component and tube assembly.
6. A catheter or tube assembly for fixing a tube, such as a drainage tube,
inserted through an opening in a patient's skin, relative to the patient's
skin, comprising:
a catheter or tube forming a drainage tube;
a plaster component including a support foil having an aperture for
receiving said drainage tube and having opposite first and second side
surfaces, said first side surface being provided with an adhesive layer
for fixing said plaster component relative to the patient's skin,
an outer support component arranged above said plaster component and
adjacent said aperture and said second side surface of said plaster
component and protruding therefrom,
said outer support component having an outer surface for supporting a
length of said tube extending from said aperture at said second side
surface of said plaster component for bending, without kinking, said
length of said tube in supported relationship with said outer support
component from an orientation substantially perpendicular to the patient's
skin to an orientation substantially parallel with the patient's skin, and
said outer support component and said plaster component being joined
together, and securing means for securing said length of said tube
relative to said plaster component said assembly further including a cover
for covering the outer support component and tube assembly.
7. The catheter or tube assembly according to claim 6 wherein said securing
means forms an integral part of said support component.
8. A catheter or tube assembly according to claim 6 wherein said securing
means is integrally connected to the plaster component.
9. The catheter or tube assembly according to claim 6 wherein said securing
means comprises an adhesive strip for fixing said tube.
10. A catheter or tube assembly according to claim 9 wherein said adhesive
strip is provided with a transparent area in the area of the aperture in
said plaster component.
11. The catheter or tube assembly according to claim 1 wherein said support
component has an aperture and is made from a sponge-like material, said
aperture being in registration with said aperture in said plaster
component.
12. A catheter or tube assembly according to claim 1 further comprising
sealing means between said plaster component and the patient's skin for
sealing around said aperture in said plaster component relative to the
outer periphery of the drainage tube.
Description
The present invention generally relates to the technique of applying and
fixating a tube, such as a drainage tube, relative to a skin surface part
of a patient or person, and more precisely a device for fixating such a
tube relative to a skin surface part of a patient or person.
It is a well-known technique to enter a drainage tube through the skin of a
patient or person in order to drain liquid from a cavity within the
patient or person, e.g. after a surgical operation. In certain
applications, the drainage tube is also used for creating a vacuum within
the cavity which is drained by means of the drainage tube. An example of
such an application is the treatment of a collapsed lung, in which
application the cavity of the thorax of the patient in question is
evacuated through a pleural drainage tube in order to cause an adhesion of
the pulmonary pleura of the patient to the costal pleura of the patient.
In all applications of drainage tubes, there exists a risk that the
drainage tube is blocked as the drainage tube is bent, or kinks of the
drainage tube are produced.
Provided the drainage tube is to be vented for creating a vacuum within the
cavity which is vented through the drainage tube, a further problem exists
in creating a reliable and lasting sealing of the entrance of the drainage
tube through the skin of the patient, and further an overall desire of
rendering it possible to create a sealing and a fixation of the drainage
tube in a swift and reliable manner. Hitherto, the drainage tube, such as
a pleural drainage tube which is used for venting the cavity of the thorax
of the patient, the lung of whom has collapsed, has been fixated and
sealed in a manual operation in which the medical doctor who applies the
pleural drainage tube arranges one or more vaseline-impregnated wads round
the pleural drainage tube at the entrance of the pleural drainage tube
through the skin of the patient and compresses the vaseline-impregnated
wads in order to create a sealing at the entrance. Thereupon, the
vaseline-impregnated wads and the pleural drainage tube as well are
fixated by means of plaster.
The technique of applying and fixating a drainage tube, in particular a
venting drainage tube, such as a pleural drainage tube, is a complex and
time-consuming operation which requires skill and which further often
turns out to be inadequate and inappropriate as the sealing of the
entrance of the pleural drainage tube through the skin of the patient in
question leaks, causing great harm to the patient.
Various devices for fixating a drainage tube have recently been developed
as disclosed in eg. U.S. Pat. No. 4,419,094 or WO 93/25264. When using
these known devices, a proximal part of the drainage tube extending from
the body of the patient through a through-going passage in the device, is
bent to form a loop whereby a distal part of the tube is fixated to the
skin surface of the patient by means of eg. a separate piece of plaster.
This procedure, however, gives rise to a potential risk of the tube
becoming blocked if the tube is inadvertently doubled or bent upon itself.
An object of the present invention is to provide a device for fixating a
drainage tube, which device to any substantial extent eliminates the risk
that the drainage tube is blocked at the entrance of the skin of the
patient in question by to any substantial extent eliminating the risk of
creation of kinks of the drainage tube.
An advantage of the device according to the present invention lies in that
a single unitary structure is provided which renders it possible, in a
single and easily performable operation, to create a fixation of the
drainage tube and also create a sealing of the entrance of the drainage
tube through the skin of the patient while at the same time ensuring that
the tube is not bent upon itself in the region of its entry to the
patient.
A feature of the device according to the present invention lies in that the
device according to the present invention constitutes a disposable unitary
strucure which has been presterilized and simply is applied as a plaster
structure to the skin of the patient.
The above object, the adore advantage, and the above feature together with
numerous other objects, advantages, and features which will be evident
from the below detailed description of preferred embodiments of the device
according to the present invention are obtained by means of a device for
fixating a drainage tube relative to a skin surface part of a patient or
person, comprising in accordance with the present invention:
a device for fixating a drainage tube relative to a skin surface part of a
patient or person, comprising:
a plaster component including a support foil having an aperture for
receiving said drainage tube, and opposite first and second side surfaces,
said first side surface being provided with an adhesive layer for fixating
said plaster component relative to said skin surface part of said patient
or person,
a support component arranged adjacent said aperture at said second side
surface of said plaster component and protruding therefrom,
said support component having an outer surface for supporting a length of
said drainage tube extending from said aperture at said second side
surface of said plaster component so as to turn said length of said
drainage tube in supported relationship with said support component from
an orientation substantially perpendicular to said skin surface part of
said patient or person to an orientation substantially parallel with said
skin surface part of said patient or person, and
said support component and said plaster component being joined together.
The support component of the device according to the present invention
fulfils the main purposes of turning the length of the drainage tube which
length extends outwardly from the aperture of the plaster component and
outwardly from the skin surface part of the person or patient to which
skin surface part the device is fixated by means of the plaster component
from an orientation substantially perpendicular to the skin surface part
of the patient or person to an orientation substantially parallel with the
skin surface part of the patient or person and also of preventing the tube
from being blocked by the turning from the above perpendicular orientation
to the above parallel orientation or through the generation of kinks or
bends on the drainage tube. A basic realization of the present invention
relates to the fact that a drainage tube extending substantially
perpendicularly out from the skin surface part of the patient or person is
to a high degree exposed to mechanical impact which may on the one hand
generate kinks on the drainage tube and on the other hand cause the
drainage tube to be removed from its intentional position relative to the
skin surface part and the interior of the patient or person to whom the
drainage tube is fixated. Furthermore, it has in accordance with the
teachings of the present invention been realized that the human body to a
high degree attempts to expell foreign bodies such as drainage tubes which
are introduced into the interior of the human body and the autonomous
expelling of a drainage tube form the human body is to a high degree
eliminated provided the drainage tube is fixated in an orientation
parallel with the skin surface part of the patient or person as compared
to an orientation perpendicular to the skin surface part of the patient or
person through which skin surface part the drainage tube extends.
Preferably, in accordance with the basic realisation of the present
invention, the outer surface of the support component is rounded for
supporting the length of the tube in a curved configuration.
According to a first embodiment, a connecting component carries the support
component, the plaster component and the support component being joined
together by means of the connecting component being fixated to the first
side surface of the plaster component. In order to provide a reliable
fixation of the device according to the present invention, and
consequently of the drainage tube relative to the skin surface part of the
patient in question, the surface part of the connecting component may be
provided with an adhesive layer for adhering to the skin surface part of
the patient or person. Preferably, the adhesive layer of the connecting
component is a biologically acceptable and/or compatible glue layer, such
as a medical grade acrylic adhesive layer or a hydro-colloid layer which
is glued to the surface part of the connecting component by means of e.g.
an adhesive layer, a glue or the like. The connecting component may have a
rectangular or a curved outline or any alternative appropriate
configuration fulfilling the basic object of the present invention.
The plaster component of the device according to the present invention may
be of any appropriate configuration, serving the purpose of providing a
reliable and lasting fixation of the flange part of the support component
relative to the skin surface part of the patient.
The support component may, according to a second embodiment particularly
adapted for pleural drainage tubes, be formed from a sponge-like material
of a biologically non-aggressive and wound-care or wound-treatment
compatible material, and having an aperture through which the drainage
tube is passed. According to this second embodiment of the invention, the
support component may be attached to the second or upper side surface of
the plaster, the plaster being formed with a relatively large
through-going aperture and the aperture of the support component being in
registration with the aperture of the plaster component. The device may
further comprise sealing means for sealing round the aperture of the
plaster component relative to the outer periphery of the drainage tube.
The device according to the present invention may comprise securing means
for fixating the drainage tube in a plane substantially parallel to the
plaster component. The securing means may be formed as an integral part of
the support component or may comprise an adhesive strip provided with
transparent apertures for checking the correct positioning of the drainage
tube relative to the patient, i.e. for checking that the tube has not
shifted, and for checking the condition of the opening in the body of the
patient. It is to be realized that in case the drainage tube does not
remain correctly positioned relative to the patient, great harm may in
some instances be incurred to the patient as e.g. the vacuum which is
created within the cavity in the treatment of e.g. a collapsed lung may
result in extremely dangerous and harmful subcutaneous swelling of large
areas of the chest and face of the patient, provided some air
unintentionally is subcutaneously vented.
The present invention will now be further described with reference to the
drawings, in which
FIG. 1 is a schematical view of a first embodiment of a drainage tube
fixating device according to the present invention,
FIGS. 2 and 3 are schematical views illustrating the technique of applying
the first embodiment of the device shown in FIG. 1,
FIG. 4 is an exploded view of the first embodiment of the drainage tube
assembly comprising the device according to the present invention shown in
FIGS. 1-3,
FIG. 5 is an schematic view of a second embodiment of the device for
fixating a drainage tube, and particularly adapted for fixating pleural
drainage tubes,
FIGS. 6 and 7 are cross-sectional views of the device of FIG. 5,
illustrating the device prior to use and in use, respectively.
FIG. 8 is a view similar to the view of FIG. 5, illustrating a third
embodiment of the device according to the present invention,
FIG. 9 is a view similar to the view of FIG. 5, illustrating a fourth
embodiment of the invention,
FIG. 10 is a cross-sectional view of a fifth embodiment of the device for
fixating a drainage tube according to the present invention,
FIG. 11 is a top view of the device of FIG. 10,
FIG. 12 is a schematical view of a sixth embodiment of a drainage tube
fixating device according to the present invention.
FIG. 13 is an exploded schematic view of a sixth embodiment of the device
according to the present invention,
FIGS. 14 and 15 are schematic views of the sixth embodiment of the device
according to the present invention, prior to and after the fixation of a
pleural drainage tube, and
FIGS. 16 and 17 illustrate a cross-sectional view of alternative
configurations of the support component of FIGS. 13-15.
In FIGS. 1-4, a first embodiment of a device for fixating a drainage tube
is shown. The first embodiment shown in FIGS. 1-4, and to be described in
greater details below, basically serves the purpose of fixating a
joint-tube catheter relative to the skin of the patient without creating
kinks or bends of the catheter,
The first embodiment of the device for fixating a drainage tube according
to the present invention further serves the overall purpose of ensuring
that the drainage tube does not become blocked due to the tube
inadvertently being doubled or bent upon itself, thereby providing a
drainage tube fixating device which render it extremely simple and far
less complicated than hitherto to fixate drainage tube to a patient,
further providing a reliable and lasting fixation.
As shown in FIG. 1 and as will be described in further details below, the
device according to the first embodiment of the invention designated in
its entirety the reference numeral 1 generally comprises a plaster
component 41 having a central aperture and carrying an adhesive layer on
the lower side thereof by means of which the plaster component 41 adheres
to the skin surface of the patient to whom the device 1 is applied, a
cover sheet 11 for covering said adhesive layer, a connecting component 31
having an aperture 4, a strip 43 carrying an adhesive layer and being
provided with a cover sheet 48, and a support component generally
indicated by the numeral 50 arranged adjacent said aperture 4 of the
connecting component 31 and having a groove 65 for receiving a drainage
tube in supporting relationship relative to the plaster component 41. The
support component 50 is fixed to the upper surface of the connecting
component 31 and protrudes from the upper surface of the plaster component
through its central aperture. As shown, the support component 50 is formed
with a slightly rounded or curved upper surface 60 providing a uniform
support for a drainage tube being turned from an orientation substantially
perpendicular to the skin surface of the patient to an orientation
substantially parallel with the skin surface. The structure of the support
component 50 will be explained in further details with reference to FIG.
4.
As shown in FIG. 2, illustrating the fixation of the device 1 according to
the present invention to the body of the patient, the outer end of the
drainage tube 5 which is a so-called pig-tail type drainage tube is
inserted through the aperture 4 of the connecting component 31, i.e. a
drainage tube which is provided with a distal end which is formed into the
configuration of a pig-tail and which to a high degree resists the
autonomous expelling of foreign bodies from the human body as compared to
a straight line drainage tube.
Alternatively, as shown, the two areas of the device 1 delimited by a slit
2, may be forced apart, thus allowing the tube to be entered into the
aperture 4. The cover sheet 11 is subsequently removed, exposing the
adhesive layer of the plaster component 41. The device 1 is as a unitary
structure shifted along the drainage tube 5 and is brought into facial
contact with the outer skin surface of the patient.
FIG. 3 shows the device according to the invention, the plaster component
having been fixated to the body of the patient. In this next step, the
drainage tube 5 is bent to a position in which it extend substantially
parallel to the skin surface of the patient. In this position, the
drainage tube is being supported by the support component 50 located
adjacent the aperture 4 through which the tube extends. The tube 5 is
taken up by the groove 65 and the cover sheet 48 of a strip 43 is removed.
By moving the securing strip 43 to the position shown on FIG. 3 in which
the lower side of the securing strip 43, which may be provided with an
adhesive layer, is in contact with the upper surface of the support
component 50 and the drainage tube 5, the drainage tube 5 is secured and
maintained in place in a position wherein the tube is turned to a position
substantially parallel with the skin surface of the patient.
In FIG. 4, the various components of the first embodiment of the device
according to the present invention is shown. The plaster component 41 as
shown has an essentially rectangular outline but may take any convenient
form according to the intended use. The plaster component 41 is provided
with a central aperture 44 delimited along one side by an edge of a
securing strip 43 formed as an integral part of the plaster component 41.
At the lower side surface, the securing strip 43 is provided with an
adhesive layer which is covered by the protective sheet 48. The plaster
component 41 is furthermore provided with an elongated slit 42.
As illustrated, the device further comprises a connecting component 31
provided with a slit 32 and an aperture 34. The connecting component 31 is
joined to the lower side surface of said plaster component 41, covering
the central aperture 44, and extending beyond its limits. A further layer
21 arranged below the connecting component 31 provides a biologically
acceptable contact between the device and the tissue at the entrance of
the drainage tube. Layer 21 may carry a hydro-colloid component (not
shown) on its lower surface, or may in fact itself constitute a
hydro-colloid material. Connecting component 31 and layer 21 respectively
may comprise an adhesive layer, or may be formed from an adhesive
material, whereby the two layers may be joined.
The cover sheet 11 covers the exposed adhesive layer of the plaster
component 41 and the exposed lower side surface of layer 21, possibly
carrying a hydro-colloid component. Alternatively (not shown), two cover
sheets of substantially identical configuration may be provided, the cover
sheets adjoining one another along a line of separation extending
substantially diametrically across the plaster component 41. The cover
sheet may be provided with a slit 12 and an aperture 14.
The support component, generally indicated by the reference numeral 50 is
formed from a pad 52, a supporting element 54 and elongated strips 56 and
58. The supporting element 54 may advantageously be provided with an
adhesive layer, preferably a resin-based adhesive, which may be exposed to
the ambience without loosing its adhesive property, on the upper side
thereof. Thus, when the drainage tube 5 is taken up by the groove 65 as
described above with reference to FIG. 3, which groove is formed by the
two elongated strips 56, 58, the tube is fixated by means of the adhesive
layer. The resinous adhesive may alternatively be provided on the top side
of a separate strip which is provided with an ordinary adhesive on the
lower side thereof, by means of which the separate strip is secured to the
upper side of the supporting element 54 in the area forming the groove 65
between the elongated strips 56, 58. By virtue of the support component 50
being arranged on the top or upper surface of the connecting component 31,
the support component 31 extends through the central aperture 44 of the
plaster component 41. This structure allows the strip 43 to be formed as
an integral part of the plaster component 41, the aperture 44 created
during the formation of strip 43 at the same time serving as a
through-going passage or aperture for the drainage tube 5. A strip of
adhesive material 92 covered by cover strip 93 may be arranged alongside
the support component on connecting component 31 with the purpose of
providing an even more reliable securing of the securing strip 43 in the
tube-retaining position shown on FIG. 3.
FIG. 12 shows an alternative embodiment 1' of the device according to the
present invention. The device 1' of FIG. 12 resembles the device 1 of
FIGS. 1-4, the support component 50 and the connecting component 31,
however, having been replaced by a single and unitary bearing element 55',
which may advantageously be formed by moulding. Thus, the bearing element
55' comprises a substantially flat or planar part and a supporting part
60' protruding therefrom. The supporting part 60' basically serves the
same purpose as the support component 50 of FIGS. 1-4 and is provided with
a groove 65', which is recessed in the surface of the supporting part 60'
and extends from an area adjacent to the aperture 4 formed in the planar
part and through which the drainage tube extends. The groove 65' forms one
or several loops along its length for providing a firm hold on the
drainage tube, and the groove may additionally be provided with an
adhesive material 67', such as a resin-based adhesive which is applied to
the basis of the groove. The walls of the groove 65' partly encompass the
aperture 4, providing a lateral support of the entire drainage tube and
providing a protective shielding of the drainage tube. The basis provides
a supporting surface for a tube which is turned from an orientation
substantially perpendicular to the skin-surface part of the patient and to
an orientation substantially parallel with the skin-surface part of the
patient.
Reference is now made to FIGS. 5-7 showing a second embodiment of the
device 100 according to the invention and particularly adapted to be
arranged at the thorax of a patient while at the same time creating a
sealing of the entrance of a pleural drainage tube into the thorax of the
patient in order to render it possible to create a vacuum within the
cavity of the thorax of the patient so as to cause an adhesion of the
pulmonary pleura of the patient to the costal pleura of the patient, and
serving the purpose of correctly entering and positioning the drainage
tube relative to the thorax of the patient. The device 100 shown in FIG. 5
generally comprises a plaster component 141 having an oval shape, and a
support component 150 attached directly to the upper surface of the
plaster component and protruding therefrom. The plaster component is
provided with an adhesive on the lower side for fixating the plaster
component 141 relative to a skin surface part of a patient or person. A
cover sheet 111 covers the adhesive and is to be removed prior to the use
of the device 100. The plaster component 141 is provided with a circular
aperture delimited by a perimeter 144. The support component 150 is
preferably made from a sponge-like material and is formed with a central
aperture 155 arranged in registration with the aperture in the plaster
component 141. The support component 150 is furthermore provided with an
elongated section 160 having a groove 165 extending from the central
aperture 155 and providing a lateral support for the drainage tube 5. The
device is furthermore provided with securing strips 143 extending
alongside the groove 165 and provided with an adhesive covered by cover
sheet 148. The bottom surface of the groove 165, which may be provided
with any suitable adhesive layer, is inclined and extends from an elevated
point at the aperture 155 to a point at the other end of the elongated
section 160 substantially at the level of the skin surface of the patient.
Securing strips 143 may be folded to a position substantially covering the
elongated section 160 and drainage tube 5, as shown on FIG. 7, whereby the
pleural drainage tube 5 is fixated in an orientation substantially
parallel with the skin surface of patient 101.
Referring now to FIGS. 6 and 7 in particular, the device 100 further
comprises a composite structure including a plurality of annular
components designated the reference numerals 170-179 fixed to the lower
side of the support component 150 at the aperture 155, which components
are provided with through-going apertures which are positioned in
registration together defining an aperture 104 through which the drainage
tube 5 is passed. The composite structure including the annular components
170-179, firstly comprises a glue layer 170 which is a hydro-colloid glue
carried by an annular element 173. On top of the annular element 173, an
annular membrane 176 is positioned which annular membrane is formed with a
central aperture of a diameter adapted to the diameter of the drainage
tube, thus sealing the aperture 104 of the device relative to the drainage
tube 5. Between the membrane 176 and the plaster component 141 an annular
plate member 179 is arranged.
The elongated strip 143 extends beyond the sides of an elongated section
160 and is sandwiched between the elongated section 160 and the plaster
component 141. As shown, a drainage tube which is a pleural drainage tube
extends from the body 101 of the person or patient substantially
perpendicularly. The pleural drainage tube 5 is fixated and sealed
relative to the patient 101 by means of the device 100.
In use, the cover sheet 111 is initially removed. The adhesive layer at the
lower side surface of the plaster component 141 together with the annular
hydro-colloid component 170 is caused to adhere to the skin surface part
of the patient. The annular hydro-colloid component 170 additionally
serves the purpose of providing a seal between the plaster component 141
and an annular skin surface part of the patient, which skin surface part
encircles the pleural drainage tube 5 and further the aperture of the skin
through which the pleural drainage tube 5 is entered into the cavity of
the thorax. The sealing membrane 176 provides a hermetical seal between
the aperture of the skin surface part through which the pleural drainage
tube 5 is entered into the cavity of the thorax and the environment. In
FIG. 7 the device 100 is shown after the device has been applied to the
patient, and clearly illustrates the facial adhesive contact between the
device 100 and the outer skin surface part of the patient 101 established
by means of the plaster component 141 and further by means of the annular
hydro-colloid component 170 which is glued or adhered to the lower side
surface of the annular carrier element 173 by means of an annular adhesive
tape (not shown). From FIG. 7, it is also evident that the support
component 150 supports the pleural drainage tube 5 at the entrance through
the skin surface part of the patient and prevents the pleural drainage
tube 5 from forming kinks or being bent upon itself.
FIGS. 8 and 9 are views similar to the view of FIG. 5, illustrating a third
and fourth alternative embodiment according to the present invention,
which embodiments are designated the reference numerals 200 and 300',
respectively, and basically serve the purpose of supporting a pleural
drainage tube as described with reference to FIGS. 5-7. The device 200 of
FIG. 8 comprises a support component 250 similar to the component 150 of
the device 100 described above with reference to FIGS. 5-7, which
component 250 comprises an elongated section 260 having a groove 265
formed therein. The support component is made from a soft, sponge-like
material and is provided with a circular aperture 255 which encompasses an
aperture 204 of a plaster component 241. A rigid, tubular element 251
provides additional support of a part of a drainage tube which passes
through the aperture 204 and is received by the groove 265.
The drainage tube, e.g. the drainage tube 5 shown in FIGS. 2 and 7, is
fixated relative to the plaster component 241 of the device 200 using a
strip 243 similar to the above described strips 43 and 143 which is
arranged on the plaster component and provided with an adhesive layer. The
strip 243 may extend along the entire length of the support component and
may be transparent in the region of the aperture 255 whereby the proper
positioning of the drainage tube may be checked.
In FIG. 9, the device 300' is shown comprising a plaster component 341' and
having an aperture 304' for a pleural drainage tube (not shown). An
adhesive has been applied to the lower side of the plaster component which
is covered by a cover sheet 311'. A support component 350' comprises an
inclined, leading edge 355' arranged adjacent to the aperture 344' and is
provided with a groove 365' formed in the leading edge 355' and in the top
surface of the support component 350' and extending to a distal portion
360' thereof, for receiving and providing lateral support for the drainage
tube. As shown in FIG. 9, the groove 365' is provided with a rounded
bottom surface leading the drainage tube in a soft curve to a position
substantially parallel to the body of the patient at the distal portion
360'.
FIG. 10 and FIG. 11 show a device according to a fifth embodiment of the
invention similar to the device described with reference to FIG. 9, the
reference numerals indicating the same elements as in FIG. 9, however,
with the omission of the '. The embodiment of FIG. 10 and FIG. 11 differs
from the device of FIG. 9 in that the walls 367 of the groove 365 partly
encompass the aperture 304, whereby a drainage tube (not shown) extending
from the aperture 304 is supported laterally from that point by the walls
367. Thus, the support component 350 provides a support for a length of
the drainage tube extending from the aperture 304 to the distal portion
360 of the support component 350, thus ensuring that the tube is at no
position bent upon itself. An elongated strip 343 is preferably joined to
the plaster component 341 at the distal portion 360 of the support
component, a distal part of the strip 343 being sandwiched between the
support component and the plaster component. As shown, the elongated strip
343 is formed with a passage 390 for the drainage tube and is on one
surface provided with an adhesive covered by a cover sheet 348. When the
cover sheet 348 is peeled off and the strip 343 is bent downwards for
adhering against the upper surface of the support component, the drainage
tube is effectively joined or locked within the groove 365, and any
upwardly directed force on the part of the tube which extends parallel to
the skin surface of the patient in the area of the passage 390 is
transmitted directly to the root of the elongated strip 343.
FIG. 10 furthermore shows a composite structure 373-379, primarily serving
the purpose of sealing the aperture 304 in relation to a drainage tube.
The composite structure basically comprises the same components as the
composite structure illustrated in FIG. 6 and FIG. 7, i.e. a carrier
element 373, an annular membrane 376 and an annular plate member 379,
defining the aperture 304 together with an aperture 344 formed in the
plaster component 341.
Reference is now made to FIGS. 13-17 which show a sixth embodiment 400 of
the device according to the present invention. As best seen in FIG. 14,
the device 400 basically resembles the device shown in FIGS. 10 and 11.
Thus, the device 400 generally comprises a support component 450 which is
attached directly to the upper surface of a plaster component 441, the
device 400 being provided with a through-going aperture 404 for a pleural
drainage tube. The support component is provided with an elongated,
groove-like recess 465 arranged in a surface part thereof. As shown in
FIG. 13, the plaster component 441 is provided with an aperture 444 and
the support component 450 is attached to the plaster component 441 such
that the walls of the groove 465 partly encompass the aperture 444 in
basically the same manner as described with reference to FIGS. 10 and 11.
Similarly, the device 400 comprises a composite struture 473-479 which is
adhesively secured to the lower side of the plaster component 441.
The composite structure 473-479 basically comprises three superimposed and
disc-like elements 473, 476, 479, each being formed with a central,
circular aperture 414, 424, 434, respectively. The composite structure
473-479 is adhesively secured to the plaster component 441 such that the
apertures 414, 424, 434 are in registration with the aperture 444 formed
in the plaster component 441, thus providing the central through-going
aperture 404 of the device 400. The disc-like element 473 is basically a
layer of a hydro-colloid substance while the element 476 is formed from
silicone. The element 479 serves as a membrane and provides a seal between
the through-going aperture 404 of the device 400 and a pleural drainage
tube 5, as shown in FIG. 14. The aperture 414 formed in the hydro-colloid
layer 473 corresponds in size to the aperture 444 formed in the plaster
component 441 and the diameter thereof is somewhat larger than the
diameter of the drainage tube 5, to allow the drainage tube 5 to extend
through the aperture 404 of the device without causing damage to the
hydro-colloid layer 473. The aperture 424 formed in the element 476 has a
diameter which substantially corresponds to the diameter of the drainage
tube while the aperture 434 in the membrane 479 is somewhat smaller than
the diameter of the drainage tube for providing a sealing effect. A
further rigid and annular element (non shown) may be arranged between the
membrane 479 and the lower side of the plaster component 441 for providing
a rigid holding means which may be grasped by the user during the
application of the device i.e. as the drainage tube is drawn or otherwise
passed through the aperture 404 of the device 400.
The device 400 also differs from the embodiment of the invention
illustrated in FIGS. 10 and 11 in that the support component 450 is formed
from three individual elements 451, 452, 453. The elements 451 and 453,
which are formed from a relatively soft foamed material, are adhesively
joined to a respective vertical side of the central element 452, which is
formed from a relatively hard or rigid foamed material. The element 452 is
provided with an upper, rounded surface which serves to support the
drainage tube 5, as indicated in FIG. 15. The dimensions and configuration
of the element 452 relative to the elements 451 and 453 is such that the
element 452 forms the recessed or groove-like part 465 of the support
component 450 whereby the elements 451, 453 provide a lateral support for
the drainage tube 5 when the drainage tube 5 is in the in use-position as
shown in FIG. 15 and as it will be described in further details below.
The support component 450 is furthermore provided with a tie 480 formed as
a flexible band which is arranged so as to partly encompass the element
452 at the end thereof most distant from the aperture 404. The tie 480 is
secured in a position surrounding the element 452 either by being threaded
through the elements 451 and 453 as illustrated in FIGS. 14 and 15, or by
being arranged surrounding the central element 452 prior to the forming of
the support component 450, as illustrated in FIGS. 16 and 17, and being
secured in said position by means of an adhesive. One end 481 of the tie
480 may be provided with barbs while the other end 482 may be provided
with an opening through which the free end 481 is drawn in a
non-releasable manner by means of the barbs.
The device 400 is furthermore provided with an elongated securing strip 443
carrying an adhesive on one side together with a cover sheet which may be
removed for exposing the adhesive. One end 446 of the securing strip 443
extends through a slit-like opening 442 arranged in the plaster component
441 adjacent to the aperture 444. The upper surface of the end 446 of the
securing strip 443 is in contact with adhesive material on the lower side
of the plaster component 441 whereby the securing strip 443 is fixed
relative to the plaster component 441.
In use, the drainage tube 5 is pulled through the aperture 404 formed in
the device 400 as shown in FIG. 14. The membrane 479 fits tightly around
the tube 5, thus sealing the point of entrance of the plural drainage tube
into the body of the patient. Following this step, the drainage tube 5 is
manually bent downwards to assume the position shown in FIG. 15, wherein
the tube 5 is continuously supported by the rounded bottom surface of the
groove 465 formed by the rounded upper surface part of the element 452
which forms the central part of the support component 450. The walls of
the groove prevents the drainage tube 5 from shifting in a lateral
direction. In this position, the drainage tube 5 is secured to the support
component by means of the tie 480 and the securing strip 443, which is
bent downwards to adhere against the upper surfaces of the support
component and the drainage tube 5, respectively.
FIGS. 16 and 17 illustrate cross-sectional views of alternative
configurations of the support component 450. The support component 450' of
FIG. 16 is provided with a recess 455' for taking up a free end of the tie
480'. The support component 450" of FIG. 17 is provided with a similar
recess 455" for taking up the free ends of a tie 480" which is operative
to secure the drainage tube 5 in position by simply twisting its ends as
illustrated schematically. As shown in FIGS. 16 and 17, a adhesive
material 457, such as a resin based adhesive, may be applied to the basis
of the groove.
It is to be realized that the embodiments described above with reference to
FIGS. 1-17 may be modified in numerous ways and further combined so as to
provide a device for fixating a drainage tube and optionally for sealing
the drainage tube or the aperture of the skin surface part through which
the drainage tube extends. Likewise, it is to be understood that the
drainage tube may be replaced by any other tube suitable for introducing a
medium into the body of the patient.
EXAMPLE
A prototype implementation of the presently preferred embodiment of the
device according to the present invention shown in FIGS. 1-4 and
designated the reference numeral 1, was made from the following
components.
The connecting component 31 was made of a PE foam. Its dimensions were
60.times.50.times.1.5 mm, the slit 32 having a length of 5 mm. The layer
21 of a hydro-colloidal material, having a thickness of 1 mm, was applied
to the lower surface of the component 31. The inner diameter of the
aperture 34 was 4 mm. The connecting component 31 was joined to the lower
or first side surface of plaster component 41 by means of the acrylic
adhesive on the lower side surface of the plaster component 41. The
plaster component 41 was formed from non-woven polyamide, and the central
opening or aperture 44, having dimensions of 30.times.50 mm, was formed by
cutting-out the segment 43 forming the securing strip 43 and integrally
connected to the plaster component 41 along one edge. The connecting
component 31 when joined to the plaster component 41 covered the entire
aperture 41 formed therein. Support component 50 was joined to the upper
surface of the connecting component 31 so as to protrude through the
aperture 44 formed in plaster component 41. The support component 50 was
formed from four separate elements: the elongated strips 56, 58 made from
a PE foam and having dimensions of 4.times.30.times.5 mm and superposed on
the supporting element 54 made from PE foam, and having dimensions of
30.times.10.times.1,5 mm, and the underlying pad 52 made from PE foam and
having dimensions of 15.times.10.times.1.5 mm. The elongated strips 56, 58
were placed parallel to one another with a spacing of 2 mm, forming the
tube-receiving groove 65, and the pad 52 was arranged underlying one end
of the supporting element 54, thus raising part of the elongated strips
corresponding to the thickness of the pad.
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